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FDA 510(k) Applications Submitted by SCOTT LIGHT
FDA 510(k) Number
Submission Date
Device Name
Applicant
K140012
01/02/2014
SORIN FLEXTHERM
SORIN GROUP DEUTSCHLAND GMBH
K130209
01/29/2013
INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED
SORIN GROUP ITALIA S.R.L.
K130433
02/21/2013
INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR, INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATE
SORIN GROUP ITALIA S.R.L.
K040831
03/31/2004
DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500
DATEX-OHMEDA, INC.
K131103
04/19/2013
XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR
SORIN GROUP ITALIA S.R.L.
K121536
05/24/2012
INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR
SORIN GROUP ITALIA S.R.L.
K191402
05/24/2019
Heater-Cooler System 3T
LivaNova Deutschland GmbH
K121909
06/29/2012
INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVIOR
SORIN GROUP ITALIA S.R.L.
K122254
07/27/2012
INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
SORIN GROUP ITALIA S.R.L.
K122735
09/06/2012
SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2
SORIN GROUP USA INC.
K122844
09/17/2012
INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL RESERVOIR
SORIN GROUP ITALIA S.R.L.
K112771
09/23/2011
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
SORIN GROUP ITALIA S.R.L.
K102983
10/07/2010
VASCUCLEAR PRECISION BIPOLAR
SORIN GROUP USA, INC.
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